On 1/1/09, Pharma instituted a voluntary ban on all gifts to physicians — the mugs, pens, post it notes, and all of the other materials involved in even further promotion of their products. The first group to applaud this move is the American Medical Student Association, to which I belonged many, many years ago.
AMSA’s PharmFree campaign has educated and trained thousands of medical students across the country to interact professionally and ethically with the pharmaceutical industry. “Banning gifts from the drug companies is a good first step,” says Dr. Brian Hurley, AMSA’s national president. “There is no role for marketing masquerading as education when our patients’ lives are at stake.”
LINK | AMSA LINK
Sunday § December 28, 2008
With the clock ticking ever so quickly toward Jan. 1, asthma sufferers will no doubt try to make a run for the border to get refill scripts on their inhalers. Because, effective that date, metered dosed inhalers must go green:
“It’s possible people may skimp on their medicine because of the cost,” said Dr. Bradley A. Becker, co-director of the Asthma Center for Children at Cardinal Glennon Children’s Medical Center in St. Louis. “Clearly that would not be a good strategy because you might end up in the emergency room.”
Many doctors have been prescribing the new inhalers for several months, helping their patients transition to the devices, which use the more environmentally friendly propellant hydrofluoralkane (HFA) and deliver the quick-relief drug albuterol.
Some physicians and pharmacists, however, say they wouldn’t be surprised to see patients rush to snag up the old inhalers, which utilize harmful chlorofluorocarbon as a propellant. The last day for the old inhalers to be sold is Wednesday.
Seems a little late for environmental concerns, don’t you think?
Wednesday § December 24, 2008
Happy Holidays from Doctor Pundit! Posting to resume 12/26/08.
In addition, almost 30 percent of seniors are taking at least five prescription medications and many combine prescription and nonprescription drugs. Among commonly used medications, drug-to-drug interactions extend beyond prescription drugs, with nearly half involving the use of over-the-counter medications or dietary supplements.
Tuesday § December 23, 2008
The NYT is reporting that, because mainly of allegations made by Sen. Charles Grassley (R-IA), a medical publishing company plans to investigate an article “improperly” ghostwritten by pharma giant Wyeth to promote its patented estrogen, Prempro. Medical ghostwriting is not a new practice. It’s merely just another promotional tool in marketing a pharma company’s product, end user beware. The problem arises, however, when the ugly spectre of misrepresentation occurs. Intentional or apparent? | LINK
Monday § December 22, 2008
Although his quest to “fix the healthcare system” currently has as much of a pie-in-the-sky altruism and idealism about it as — say, ending the Iraq War — there is much the future President Barack Obama can do on the issue of healthcare delivery immediately upon swearing in office in January. At the top of the list is revisiting the current President George W. Bush-led legislation involving the so-called “conscience rule”, which gives healthcare providers an out when faced with the possibility of performing procedures or prescribing medicines (notably, those treatments involving family planning) that might not square with their moral beliefs. Obama et al. promise to prioritize dismantling of this healthcare legislative piece, initially by allowing the Democratic controlled Congress to hamper its implementation. | LINK
Saturday § December 20, 2008
The FDA is now recommending that all new drugs developed for the treatment of type 2 diabetes show that they do not increase the risk of cardiovascular events.
The recommendation is included in a new guidance document issued this week by the agency and emerges after concerns have been raised about the cardiovascular safety of drugs in this field, especially the thiazolidinediones, the drug class which includes the much maligned rosiglitazone. The new standard is effective immediately and affects all drugs and biologics currently in development.
Last July, the Endocrinologic and Metabolic Drugs Advisory Committee voted overwhelmingly in favor of requiring sponsors to conduct long-term clinical trials or provide equivalent evidence ruling out an unacceptable cardiovascular safety risk. Based on that two-day meeting, the FDA is now asking sponsors for more stringent clinical trials that collect data on cardiovascular end points, as well as studies that include real-world patients likely to be seen in clinical practice. | LINK
Friday § December 19, 2008
Thursday § December 18, 2008
As the Obama cabinet begins to take shape, groups on either side of the regulatory aisle are firing off letters to HHS Sec’y-Elect Tom Daschle in an effort to influence opinion in the choice of the next FDA commissioner. Essentially, that choice comes down to a couple of possibilities: (1) a candidate who represents the interests of the drug and device lobby as an efficient healthcare-as-free-market savior, eschewing excessive government regulation as both wasteful and intrusive; or (2) a candidate who can balance the need for safety in healthcare product delivery and promotion with the government funding specifically earmarked for this purpose. The selection of the new FDA chief will a closely watched one because an essential part of healthcare delivery reform will involve strong checks and balances in the powers of agencies, like the FDA, charged with protecting the public’s interest, as opposed to their own “saving face”. | LINK
Wednesday § December 17, 2008
How about holding a house party discuss healthcare policy reform, and inviting some unexpected guests: among them — the insurance companies? Interest and advocacy groups representing the entire healthcare delivery spectrum will be holding informational sessions all over the country in anticipation for the culture of healthcare accountability Barack Obama has proposed as a policy point. Organizations from the AMA to America’s Health Insurance Plans, from state medical societies to pharma and device lobbies will all be taking part in these strategic listening sessions in which local physicians are urged to take an active part. Culture of accoutability in healthcare? It appears as though Barack Obama wants full disclosure, like, yesterday. | LINK
Tuesday § December 16, 2008
Never has the need for transparency been greater for the Medicare Part D drug plan than when the new so-called reference-based pricing will begin on covered branded drugs possessing generic equivalents, in January. Under this plan, beneficiaries will have to pay an additional fee for these drugs under Part D, as opposed to other drugs which have no generic equivalent. Let the confusion begin.
[C]ritics complain reference-based pricing can result in hidden charges. “I am concerned that beneficiaries could find themselves paying far more out-of-pocket than they expected,” Rep. Pete Stark, chairman of the House Ways and Means health subcommittee, recently wrote in a letter to the Centers for Medicare and Medicaid Services. “CMS needs to make sure that beneficiaries are aware of these penalties before they choose their plans.”
Is this a job for the new HHS Secretary? | LINK
Monday § December 15, 2008
Sunday § December 14, 2008
A class action lawsuit has been filed against Medtronic, Inc. on behalf of shareholders, alleging that the company made false and misleading statements that failed to disclose their Infuse Bone Graft problems and the extent to which sales of the bone stimulator were dependent on “off-label” uses the company was promoting, which have been associated with a number of serious and life-threatening complications. The plaintiffs allege that the company concealed or failed to disclose the extent to which revenues were dependent on applications of the Infuse Bone Graft that were not approved by the FDA, and which Medtronic had not established as safe or effective. They also indicate that the company failed to disclose that a significant number of patients who received the Medtronic Infuse Bone Graft for an unapproved use, were suffering severe medical complications. | LINK
Friday § December 12, 2008
Initially, this story wasn’t gaining much traction, but as the debate over the safety of these drugs grows increasingly more voluble, the implications for recall (at least in the treatment indication for asthma) are real.
The two drugs are the single-agent long acting beta2 agonist inhalers salmeterol (GlaxoSmithKline PLC’s Serevent) and formoterol (Novartis AG’s Foradil). If the FDA follows the panel advice and withdraws approval for asthma treatment, the two drugs would still be indicated for treatment of COPD, which accounts for about half their current use, said a report in MedPage Today. The FDA does not have to follow the recommendations of its advisory panels, but it usually does.
LINK
