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Archive for the ‘Media-TV’ Category

Dr. David W. Goodman “Ask the Expert” Webinar for the National Resource Center for ADHD, “The Representation of ADHD in the Media”


On February 5, 2014 Wednesday at 3:00pm, I will be providing a webinar on “The Representation of ADHD in the Media”. The webinar is sponsored by the National Resource Center for ADHD, supported by a grant for the Centers of Disease Control. The topic was chosen after a number of recent articles on ADHD in national publications. Given my media experience, I was invited to provide an educational overview to how articles are developed, discerning the subtext, and advocating for input for those who deal with ADHD everyday.

I hope to provide the participants with a “behind the curtain” insight to the positive and negative representations in local and national press. My presentation with slides will be 25 minutes followed by 30 minutes of Q and A. Please join us.

You may wish to view transcripts of previous “Ask the Experts” presentations by leading experts. This is a treasure trove of information.

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Brain wave device for ADHD approved by the FDA


If you get ADHD alerts or listen to the media, you may have heard of the FDA approval for a brain wave test to aid in the diagnosis of ADHD. The study involved 275  children between ages 6-17. The test is an EEG and they say that the ratio of specific brain waves (theta and delta) increase the accuracy of making the ADHD diagnosis.

Here are my reservations:

1. The FDA has not released the study data so there is no way for researchers and clinicians to review the merits of the study.

2. Study methodology can strongly influence the data and subsequent interpretation.

3. We don’t know the threshold of benefit that was used by the FDA to merit the approval. The threshold was not indicated in their approval statement.

4. I’m unable to locate the study as a scientific publication at the NIH publication database (www.pubmed.com)

5. What you may be reading in the media is simply a combination of the FDA’s statement of their approval and the press releases by the company who sought the approval.

6. Historically, attempts to find diagnostic tests like this for ADHD have been very elusive and ultimately of little added benefit in clinician practice.

7. Resist the “sales” pitch of practitioners to use and bill for this “test”. The prescribed treatment will still be the same, regardless of the “test” results.

Until the study or studies are publically available for scientific review, please be skeptical.  If it proves to useful, the studies will clearly indicate it.  Until then…..

David W. Goodman, M.D.

Copy Cat Crimes since Aurora shooting


The tragedy of Aurora has raised the issue of copy cat crimes, in this case, shootings or threats of shootings. I was asked to provide a psychiatric insight to WUSA Channel 9 News in Washington, DC about copy cat crimes and those people who might take such action.

Copy cat crimes have been a phenomena that occurs around the world. This has been recognized by the Centers for Disease Control and the World Health Organization. Some research supports the idea the media coverage sensationalizing the crime can contribute to copy cat crimes. Conversely, the absence of coverage of the events decreases the likelihood of copy cat crimes. The media is aware of this research and attempts to strike a balance in the reporting these events to the public.

See this excellent report televised today, August 2.

David W. Goodman, M.D.

Categories: Media-TV, News

URGENT ALERT Counterfeit Teva Adderall 30 mg pills online


This morning the FDA’s MedWatch posted the following alert to physicians and patients concerning counterfeit Adderall 30 mg tabs from Teva Pharmaceuticals. These “Adderall” tablets don’t contain the four amphetamine salts as it should be. These tablets contain a combination of tramadol (pain medication) and acetominphen (tylenol).  READ THE FOLLOWING ALERT AND ADVISE ANYONE OBTAINING THIS MEDICATION ONLINE.

 

Teva’s Adderall 30 mg Tablets: Counterfeit Product – Contains Wrong Active Ingredients

AUDIENCE: Consumer, Health Professional

ISSUE: FDA is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. FDA’s preliminary laboratory tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.

BACKGROUND: Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance – a class of drugs for which special controls are required for dispensing by pharmacists. The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers. Authentic Adderall 30 mg tablets produced by Teva are round, orange/peach, and scored tablets with “dp” embossed on one side and “30” on the other side of the tablet.

See the Press Release for pictures of the product.

RECOMMENDATION: Anyone who believes they have the counterfeit version of Teva’s Adderall 30 mg tablets should not take or should stop taking the product. Consumers should talk to their health care professional about their condition and options for treatment.

Yeardley Love Murder Defense


The Yeardley Love murder trial has started in Charlottesville, VA this week. I was invited by Fox TV (WBFF) in Baltimore to speak to the defense’s position that alcohol and adderall were the cause of death, not the head injury. My interview excerpts will likely be aired sometime over the next 2 weeks.

In reviewing the specific information on alcohol and adderall in this tragic murder, I share below public information (NBC29.com) on autopsy findings.

“Through testimony from Dr. William Gormley, the man who performed Love’s autopsy, we learned that she had a blood alcohol content of 0.14; nearly twice the legal limit if she had been driving. He also said there were no fractures to Love’s skull but her brain was riddled with contusions, and the alcohol in her system was not sufficient to cause death.” 

“Love also had a trace of a prescription amphetamine in her system (0.05ng/ml this I added from another source) consistent with the Adderall she took to help with her ADHD. Gormley testified that he did not believe the amphetamines were a contributing factor to her death.”

In regards to adderall, Yeardley was prescribed adderall under medical care. Adderall can be detected in blood up to 24 hours later so it is difficult to know when she had taken her dose of medication. Very likely it was taken much earlier in the day. The level is so low as to be relatively inconsequential in regards to clinical impact.

Two recently published studies reviewing the serious cardiovascular risks of stimulants in children, adolescents and adults found no association between stimulants and risk of myocardial infarction (heart attack), stroke, or sudden death. These two studies (NEJM, JAMA) represent the largest databases ever reviewed on stimulants and serious cardiovascular risks. There is additional study underway by the NIMH that is not yet published.

In my opinion, given that Yeardley was a seasoned athlete who would have had a pre-sports cardiogram and her heart was subjected to extreme athletic conditions without symptoms, the likelihood that alcohol and adderall provoked a cardiac arrthymia and sudden death is almost non-existent and wouldn’t rise to the level of consideration, especially in light of the more obvious cause of death determined by the medical examiner, “blunt force head trauma”.

We’ll await the presentation of additional facts in court and the jury’s conclusion.

So sad for all involved.

David W. Goodman, M.D.

ADHD Stimulant Shortage Video Maryland Public Television Jan 30, 2012


Watch my interview from Maryland Public Television live 15 minute interview by Jeff Salkin on Direct Connection with Jeff Salkin on January 30, 2012 Monday at 7:30 pm discussing the recent problematic shortage of ADHD stimulant medications. I offered explanations for the shortages and “work arounds” for patients. Let me know what you think.

David W. Goodman, M.D.

FDA, Pharmaceutical Companies, and Stimulant Shortages


 

Maryland Public Television has invited me to a live interview by Jeff Salkin on Direct Connection with Jeff Salkin on January 30, 2012 Monday at 7:30 pm to discuss the recent problematic shortage of ADHD stimulant medications. I will review the possible causes and make suggestions to “work around” the shortages for parents and patients.

As a preview to the show and for those who read my blogs, I have provided the FDA’s recent tables highlighting the manufacturers explanations for shortages. You will notice there are several companies making the medications so no one company can be held to blame. This is an industry issue entailing regulatory, manufacturing and economic factors.

Join us Monday night for my detailed explanations. Following the program, I will blog the detailed information I offered in the interview with further links.

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

Amphetamine Mixed Salts, ER Capsules  (updated 10/31/2011)

Company/Products Reason Related Information
Shire Customer Service:
1-800-828-2088Adderall XR capsules
5 mg – 100 count (NDC 54092-0381-01); 10 mg – 100 count (NDC 54092-0383-01); 15 mg – 100 count (NDC 54092-0385-01); 20 mg – 100 count (NDC 54092-0387-01); 25 mg – 100 count (NDC 54092-0389-01); 30 mg – 100 count (NDC 54092-0391-01)
API supply issues and uneven product distribution patterns. Product availability for all dosage strengths is adequate.
Teva Customer Service
(888)838-28725 mg – 100 count (NDC 00555-0790-02); 10 mg – 100 count (NDC 00555-0787-02); 15 mg – 100 count (NDC 00555-0791-02); 20 mg – 100 count (NDC 00555-0788-02); 25 mg – 100 count (NDC 00555-0792-02); 30 mg – 100 count (NDC 00555-0789-02)
API supply issues Teva continue to release product as it becomes available.
Global Customer Service:
(215)558-430010 mg ,100 count (NDC 00115-1329-01); 15 mg, 100 count (NDC 00115-1330-01); 20 mg, 100 count (NDC 00115-1331-01); 25 mg, 100 count (NDC 00115-1332-01); 30 mg, 100 count (NDC 00115-1333-01)
Inadequate finished product supply to support current market demand All finished product strengths are currently available on an allocated basis.

Amphetamine Mixed Salts Immediate-Release Tablets (updated 1/12/2012)

Company/Products Reason Related Information
Sandoz Customer Service:
1-609-627-85005 mg tablets, 100 count (NDC 00185-0084-01)10 mg tablets, 100 count (NDC 00185-0111-01)

20 mg tablets, 100 count (NDC 00185-0401-01)

30 mg tablets, 100 count (NDC 00185-0404-01)

Increase in demand Releasing product as it becomes available.
CorePharma
1-800-850-27195 mg tablets, 100 count (NDC 64720-0130-10)10 mg tablets, 100 count (NDC 64720-0132-10)

20 mg tablets, 100 count (NDC 64720-0135-10)

30 mg tablets, 100 count (NDC 64720-0136-10)

Increase in demand CorePharma is releasing product as it becomes available.
Teva Customer Service:
1-888-838-28725 mg tablets, 100 count (NDC 00555-0971-02)7.5 mg tablets, 100 count (NDC 00555-0775-02)

10 mg tablets, 100 count (NDC 00555-0972-02)

12.5 mg tablets, 100 count (NDC 00555-0776-02)

15 mg tablets, 100 count (NDC 00555-0777-02)

20 mg tablets, 100 count (NDC 00555-0973-02)

30 mg tablets, 100 count (NDC 00555-0974-02)

Adderall, 5 mg tablets, 100 count (NDC 00555-0762-02)

7.5 mg tablets, 100 count (NDC 00555-0763-02)

10 mg tablets, 100 count (NDC 00555-0764-02)

12.5 mg tablets, 100 count (NDC 00555-0765-02)

15 mg tablets, 100 count (NDC 00555-0766-02)

20 mg tablets, 100 count (NDC 00555-0767-02)

30 mg tablets, 100 count (NDC 00555-0768-02)

API supply issues Teva continue to release product as it becomes available.

Dextroamphetamine Tablets (1/12/2012)

Company/Products Reason Related Information
Teva Pharmaceuticals
1-800-545-88005 mg tablets, 100 count (NDC 00555-0952-02)
10 mg tablets, 100 count (NDC 00555-0953-02)
Manufacturing delays Teva has dextroamphetamine 5 mg and 10 mg, 100 count tablets, will be on intermittent back order through mid-2012. Product will be released as it becomes available.

Methylphenidate HCl (updated 1/12/2012)

Company/Products Reason Related Information
Sandoz Customer Service:
1-609-627-85005 mg (100s – NDC 00781-8840-01 & 00781-5748-01; 1000s – NDC 00781-8840-10), 10 mg (100s – NDC 00781-5749-01 & 00781-8841-01; 1000s – NDC 00781-1749-10), 20 mg (100s – NDC 00781-8842-01 & 00781-5753-01; 1000s – NDC 00781-1753-10)20 mg (100s – NDC 00781-8843-01 & 00781-5754-01)
Capacity constraints and receiving API orders. Expect sporadic backorders for the next couple of months.
Mallinckrodt Customer Service:
(800) 325-88885 mg (100s – NDC 00406-1121-01; 1000s – NDC 00406-1121-10), 10 mg (100s – NDC 00406-1122-01; 1000s – NDC 00406-1122-10), 20 mg (100s – NDC 00406-1124-01; 1000s – NDC 00406-1124-10) Methylin ER, 10 mg (100s – NDC 00406-1423-01) and 20 mg (100s – NDC 00406-1451-01)
Continued recovery as a result of previously unavailable raw material All strengths of methylphenidate IR and ER tablets will be increasingly available as supply recovery continues, with most contracted orders being met.
UCB Customer Service:
1-800-477-78775 mg (100s – NDC 53014-0531-07), 10 mg (100s – NDC 53014-0530-07), and 20 mg (100s – NDC 53014-0532-07)Metadate ER Tablets, 20 mg (100s – NDC 53014-0594-07)

Metadate CD, 10 mg (100s – NDC 53014-0579-07), 20 mg (100s – NDC 53014-0580-07), 30 mg (100s – NDC 53014-0581-07), 40 mg (100s – NDC 53014-0582-07), 50 mg (100s – NDC 53014-0583-07), and 60 mg (100s – NDC 53014-0584-07)

Increased demand
UCB is currently out of stock of our 5 mg IR, 10 mg IR and 20 mg IR and our 20 mg ER products.  UCB expects resupply by February.
Watson Customer Service:
(973) 355-83005 mg (100s – NDC 00591-5882-01), 10 mg (100s – NDC 00591-5883-01), and 20 mg (100s – NDC 00591-5884-01)
n/a Watson has all 3 strengths available for contracted customers only.
Noven Customer Service:
866.663.2539 
Daytrana (Methylphenidate Transdermal System)
10 mg (30s – NDC 68968-5552-3)
15 mg (30s – NDC 68968-5553-3)
20 mg (30s – NDC 68968-5554-3)
30 mg (30s – NDC 68968-5555-3)
Not applicable
Currently all product is available