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FDA, Public Health, Research

The importance of including risk information in ads for over-the-counter medications

Findings published today in the Journal of the American Medical Association show that when prescription medications become available over-the-counter, advertisements for the products are less likely to alert consumers to potential risks or side effects.

In the study (subscription required), Brigham and Women’s Hospital researcher Jeremy Greene, MD, PhD, and colleagues examined print and broadcast advertisements for four commonly used medications that were marketed to consumers as prescription drugs and later approved for over-the-counter sale. The advertisements ran for 24 months before and six months after the switch to over-the-counter. The researchers found that when drugs required a prescription, 70 percent of the advertisements mentioned potential risks and side effects. However, once drugs were available without a doctor’s signature, this figure dropped to 11 percent.

Greene discusses the findings in a Q&A on news@JAMA. He had the following to say about why risk information in advertisements is necessary for patients and how he hopes this study will be useful to physicians:

When the average consumer thinks about an OTC drug, they think this drug has to be safe or it wouldn’t be available without a prescription. But as any pharmacologist knows, there is no such thing as a safe drug. Our most potent cures can be poison if used improperly, and that is just as true for OTC drugs.

It is increasingly important to know all of the substances a patient is taking. We understand that the total amount of acetaminophen consumed can shift it from a safe medication to one of the leading causes of emergency department visits and liver failure. It’s important for us to know the landscape of promotion and how it influences consumers’ perceptions of medication risks.

Previously: Report shows over 60 percent of Americans don’t follow doctors’ orders in taking prescription meds and One label fits all? A universal schedule for prescription drugs
Photo by PinkMoose

FDA, In the News, Science Policy, Stem Cells

U.S. District Court rules that stem cells are drugs

Peter Aldhous from New Scientist reports today that the U.S. District Court in Washington, DC, has ruled that a person’s own cultured stem cells are drugs subject to regulation by the Food and Drug Administration.

This is a big deal, as it’s the cornerstone of an ongoing argument between the agency and Colorado-based Regenerative Sciences (The FDA Law Blog summarized the legal tussles nicely last October). It’s also germane to the issues surrounding Texas-based Celltex, which I’ve blogged about before.

According to Aldhous:

It’s official: stem cells are drugs. At least, that’s the opinion of the [court]… which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies.

Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice – not regulated by the US government. But if the cells are subjected to more than “minimal manipulation”, the FDA maintains that the therapy becomes a “drug”, which must be specifically approved for use.

Aldhous also quotes Regenerative Sciences’ medical director Christopher Centeno, MD, vowing to appeal the ruling, as well as Stanford’s own Christopher Scott:

“I think it’s a good ruling, and I’m glad to see that that the FDA has exercised its muscle on the case,” says Christopher Scott, who heads the Program on Stem Cells in Society at Stanford University in California.

Scott hopes that the FDA will now step up its efforts to regulate other clinics offering unproven stem cell therapies. These include Celltex of Sugar Land, Texas, which rose to prominence after Texas governor Rick Perry was injected with stem cells supplied by the company to aid his recovery from back surgery.

This is obviously not the last of the story– we’ll keep you posted.

Previously: FDA audit of Texas stem cell clinic revealed by Houston Chronicle and Stanford’s Irving Weissman on the (lost?) promise of stem cells
Photo by sideonecincy

FDA, HIV/AIDS, In the News

Truvada: Not a magic bullet for preventing HIV

Truvada: Not a magic bullet for preventing HIV

As you may have heard, the U.S. Food and Drug Administration yesterday approved the drug Truvada as a preventative measure for HIV-negative individuals who are at high-risk for contracting the virus. The pill, which is already used in patients with HIV, has been shown to reduce the risk of infection.

A segment on KQED’s California Report today focused on some of the controversies surrounding Truvada’s approval, including concerns from doctors and researchers about how the drug could encourage users to forego safe sex practices. Andrew Zolopa, MD, director of the Stanford Positive Care Clinic, told reporter Joshua Johnson:

There’s no magic bullet here. It’s not just a pill by itself – it really does require careful prevention planning, safe sex education, the use of condoms… All of those things still are required as well as medical monitoring for the medication, because of course there are side effects to medications. All medications, even a medication as good as the one that’s just been approved for prevention, Truvada, do have side effects.

Previously: FDA panel recommends use of new cost-effective tool to curb AIDS epidemic, Preventing HIV with daily drug is costly but useful and Treat patients early to stop HIV spread, study finds

Cardiovascular Medicine, Clinical Trials, FDA, Stem Cells

Stem cell-based heart-attack therapy approved for clinical trials

Marking a first for the California Institute for Regenerative Medicine, the FDA has given the go-ahead for clinical trials on a stem-cell based approach to repairing damage caused by heart attack. CIRM provided funding to the Cedars-Sinai Heart Institute researchers who worked on the potential therapy; as noted in a press release, “this is the first time that research by a CIRM-funded Disease Team has resulted in an Investigational New Drug (IND) approval from the FDA.” More from the release:

The therapy, which will be taken forward by Los Angeles-based biotechnology company Capricor, uses Cardiosphere Derived Cells (CDCs) to reduce scarring and repair the damage caused to heart muscle by a heart attack. The cells are found in heart tissue and have the potential to change into a variety of different heart cell types. The CIRM funded work enabled development of an “off the shelf” product that has the potential to treat large numbers of patients and be available whenever a patient needs it.  The theory is that these cells will help support the heart’s own healing mechanisms.

In preliminary studies with a related product derived from the patient’s own cells (e.g., not an “off the shelf” product), giving patients these modified CDCs were shown by an imaging study to reduce the amount of scarring left by the heart attack.

FDA, In the News, Stem Cells

FDA audit of Texas stem cell clinic revealed by Houston Chronicle

I haven’t written much about it here, but I’ve been following carefully the ongoing drama between the Food and Drug Administration and a Texas stem cell clinic, Celltex. (Texas Governor Rick Perry underwent experimental injection of his own adult stem cells last year, and thrust Celltex into the spotlight.) Today the Houston Chronicle published portions of documents from an agency audit of the clinic in April, obtained through a Freedom of Information Act filed by University of Minnesota bioethicist Leigh Turner, PhD. According to the paper:

In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection.

At issue is whether Celltex, or other similar companies, can remove adult stem cells from a patient, culture them in a lab and then reinject them into the same patient from which they were derived. U.C. Davis stem cell researcher Paul Knoepfler, PhD, included on his well-regarded stem cell blog a damning comment today from Turner:

Since February, many individuals have expressed both concern and outrage in response to Celltex’s involvement in processing mesenchymal stem cells, banking stem cells, and making these cells accessible to individuals with such illnesses as multiple sclerosis and Parkinson’s disease.  Among various issues raised by bioethicists, scientists, journalists, and other individuals who have investigated Celltex’s operation in Texas are fundamental questions about whether the stem cells Celltex provides to patients are safe and effective. Celltex has failed to make any attempt to demonstrate safety and efficacy and yet it charges patients with serious illnesses $20,000 to $30,000 for stem cell “infusions.” There is no reason to assume that these procedures are safe and effective.  To the contrary, by providing local physicians with clinically unproven stem cell interventions Celltex is putting patients at risk of harm.

The California Institute for Regenerative Medicine also weighed in today, no doubt trying to mitigate any overall negative fallout for the field of adult stem cell research, emphasizing how important it is for stem cell companies to work with regulators like the FDA to bring the best therapies to patients.

The as-yet-unresolved role of Celltex and other adult stem cell clinics in this country is one all stem cell researchers and reporters should be watching with interest. It pits patients, many of whom feel their own stem cells (and how they and their physicians choose to use them) should not be subject to government oversight, against regulators who argue that these cells (once removed from the body and grown in a laboratory) should at least be shown to be safe and effective before the technique is commercially marketed to patients.

Previously: Stanford’s Irving Weissman on the (lost?) promise of stem cells, Stem cell researchers challenge clinics’ questionable practices, and Bioethicist Arthur Caplan slams unproven stem cell clinics

Dermatology, FDA, In the News

Medical experts question the safety of spray-on tanning products

Medical experts have advised wearing sunscreen outdoors and staying out of tanning beds altogether to reduce preventable skin damage and other health risks. But those still aiming to look like the Bronze Idol from the 19th century ballet La Bayadère may also want to hold off on even a sunless tanning approach. Evidence suggests that spray tanning may not be a safe alternative to ultraviolet exposure.

Today, ABC News reports that spray tans’ active chemical, dihydroxyacetone (DHA), may damage DNA and cause genetic alterations. A literature review performed by six medical experts with expertise spanning dermatology, toxicology and pulmonary medicine has raised questions about the safety of DHA. The chemical was approved by the U.S. Food and Drug Administration in 1970s for external use; back then, it was tanning lotions, not sprays, that were ubiquitous.

Scientists worry that when sprayed without protecting body cavities and mucous membranes, the chemical could be inhaled, ingested, or absorbed through the skin into the bloodstream – all falling outside of the approved use of DHA and possibly making the body vulnerable to its harmful effects.

From today’s article:

[Rey Panettieri, MD], like all the experts ABC News consulted with, said more studies should be done. He emphasized the available scientific literature is limited. Still, he said, he has seen enough to say the warning signs of serious health concerns exist.

“These compounds in some cells could actually promote the development of cancers or malignancies,” he said, “and if that’s the case then we need to be wary of them.”

The full investigative report is worth a read.

Previously: Study shows link between indoor tanning and common skin cancer and Intense, rapid sun tanning may increase skin cancer risk
Photo by Dr Stephen Dann

Cancer, Clinical Trials, Dermatology, FDA, Stanford News

Studies show new drug may treat and prevent basal cell carcinoma

Studies show new drug may treat and prevent basal cell carcinoma

Each year approximately 2.8 million people in the United States are diagnosed with basal cell carcinoma (BCC), the country’s most common form of cancer. New studies published today in the New England Journal of Medicine show the drug vismodegib (trade name: Erivedge) may help treat and prevent this type of skin cancer that is rarely fatal but potentially disfiguring.

Three papers, all with Stanford authors, demonstrate the effectiveness of vismodegib. The first U.S. Food and Drug Administration-approved drug in its class, vismodegib was shown in two of the studies to be effective in treating advanced or metastatic BCC tumors.

According to our release, one clinical trial, tested the use of vismodegib to treat patients who have Gorlin syndrome, which is characterized by tens to hundreds of BCC tumors. A second clinical trial tested the drug’s effectiveness in treating advanced basal cell carcinomas. From the release:

In the study of the drug’s effect on patients with Gorlin syndrome (also known as Basal Cell Nevus Syndrome) the researchers showed that subjects taking vismodegib developed an average of two new tumors per year, compared with 29 new tumors in subjects taking placebo. The drug is taken daily in a pill form. This investigator-initiated, double-blind placebo trial involved 41 patients with Gorlin syndrome and was stopped early due to the overwhelming effectiveness of vismodegib, the article states. It was considered unethical not to offer the drug to those participants taking a placebo.

The second of the three papers presents the findings from the phase-2 Genentech-sponsored clinical trial that were the basis for the FDA’s decision to allow vismodegib to be used to treat advanced forms of BCC in adults. The drug was successful 43 percent of the time in either complete or partial shrinkage of tumors in the 96 patients with advanced disease who participated in the trial, the study reports.

Researcher and author on two of the studies Anthony Oro, MD, PhD, professor of dermatology at Stanford, was most excited about having a treatment for many of his patients who are running out of options:

We now have a brand new class of drugs that can treat these cancers. As a dermatologist, this is exciting to see. There is nothing for these patients that works. Their cancers are often surgically inoperable.

Previously: Hope for basal cell carcinoma prevention? and Common drug might help prevent skin cancers

FDA, HIV/AIDS, In the News

FDA panel recommends use of new cost-effective tool to curb AIDS epidemic

In a very promising step forward, a U.S. Food and Drug Administration panel has taken the unusual step of recommending approval of the first once-a-day pill to prevent HIV. The panel suggested the pill be prescribed for people at high-risk of infection, such as gay men with multiple sex partners. The hope is to reduce the number of new infections in the United States, which reached 56,000 last year (in a talk last month at Stanford, Anthony Fauci, MD, head of NIAID, called this number “embarrassing”).

The move comes on the heels of a Stanford study (subscription required) that found use of the pill, marketed as Truvada, could be cost-effective if targeted at these high-risk groups. The Stanford study, published last month, found that if the pill were prescribed to just 20 percent of high-risk gay men – those with five or more sexual partners a year – some 41,000 new infections could be prevented over 20 years at a cost of about $16.6 billion.

“Adopting (the pill) for men who have sex with men at high risk of acquiring HIV is an investment with good value that does not break the bank,” Jessie Juusola,  a PhD candidate and the study’s lead author said at the time.

A landmark trial published in 2010 found the pill could reduce an individual’s risk of infection by 44 percent when taken daily. Patients who religiously followed the daily regimen reduced their risk to an even greater extent – by 73 percent, the trial results showed.

Scientists caution, however, that patients still need to be monitored for side-effects from the pill, which can affect the kidneys. Moreover, they need to be counseled to continue to use condoms and other protective measures, as the pill isn’t foolproof.

Previously: Anthony Fauci: End of AIDS pandemic in sight, Preventing HIV with daily drug is costly but useful and Treat patients early to stop HIV spread, study finds

Clinical Trials, FDA, Health Policy, Stanford News

New ideas to help FDA discover drug risks

The U.S. Food and Drug Administration sometimes finds out that a drug it has approved for the market has dire and unanticipated side effects. A report released today by the Institute of Medicine suggests steps to help the agency catch such problems earlier in the process.

A key point is for the FDA to use more vigorously its authority to order additional studies after a drug is on the market. “Right now many studies are commissioned mainly when there’s a fire,” said Stanford Professor Steven Goodman, MD, PhD, a co-chairman of the Institute of Medicine (IOM) committee that produced the report, in an interview with me last week. “We think it’s better to initiate them when there’s just smoke.” Goodman is the medical school’s associate dean for clinical and translational research and a professor of medicine and of health research and policy.

The report comes as Congress is considering legislation reauthorizing the user fees that help to fund the FDA and is weighing ways to improve the agency’s drug-approval and tracking systems. Recent situations with the antidiabetes drug Avandia, the pain-reliever Vioxx and the cholesterol-reducing drug Crestor underscore the need to adopt new safety measures. The report proposes some factors that could indicate the need for a post-approval study. According to a release from the IOM:

[The report] identified some circumstances in which a product’s benefits or risks are particularly uncertain, including “first in class” drugs that have been approved based on surrogate endpoints used previously for other drug classes, and drugs for which several endpoints provide conflicting evidence about risk, such as an anti-hypertensive drug that lowers blood pressure but increases weight. In such cases, the committee recommended that FDA require safety research after approval or provide a public rationale for why it is not necessary. Early initiation of such studies could limit the harm done by drugs with risks that are later found to be unacceptable and avoid crises in which the agency is faced with few good options, the committee said.

Addiction, FDA, Health Policy, In the News

What’s being done about the way tobacco companies market and manufacture products

What's being done about the way tobacco companies market and manufacture products

A week ago at Med School 101, an annual Stanford event for area high-schoolers, I sat in on a session by tobacco expert Robert Jackler, MD. The Edward C. and Amy H. Sewall Professor in Otorhinolaryngology, Jackler serves as principal investigator of Stanford Research into the Impact of Tobacco Advertising. His session, “Get ‘em young and train ‘em right: How the tobacco industry targets teens,” detailed ways advertising transforms healthy teens into lifelong smokers.

Jackler took an historical view of the gimmicks employed in print and television ads since the mid-twentieth century. (The one I found most disturbingly catchy was this 1952 Old Gold commercial featuring tap-dancing cigarette cartons in what appears to be a mother-daughter duet.) Besides equating smoking with fun and obscuring the real dangers it poses, tobacco companies have worked around bans on flavored cigarettes by sweetening or spicing up various forms of smokeless tobacco, Jackler pointed out.

Fresh from my Med School 101 primer, I was interested to read today about the latest step by the Food and Drug Administration to fight the tobacco epidemic and “prevent misleading marketing about the risks associated with tobacco products.” An FDA release announced its two new guidance documents:

The first document provides guidance on how companies will comply with the requirement to report on the quantities of potentially harmful chemicals in tobacco products. The second document provides guidance to companies that seek to advertise or market a tobacco product as less harmful or associated with reducing the risk of tobacco-related disease.

“We are  forging new territory to ensure that tobacco companies provide accurate information and do not mislead American consumers,” said FDA Commissioner Margaret Hamburg, M.D. “We are committed to stopping such practices that may cause people to start or continue using tobacco products that could lead to preventable disease and death.”

An Associated Press article in USA Today provides some more background on the second guidance:

The FDA’s handling of modified-risk products has been highly anticipated by both the public health community and bigger tobacco companies, which are looking for new products to sell as they face declining cigarette demand due to tax increases, health concerns, smoking bans and social stigma.

Previously: How have U.S. tobacco regulations affected smokers?, Study shows anti-tobacco programs targeting adults also curb teen smoking and A conversation about the FDA’s new graphic health warnings for cigarettes
Photo by DLSimaging

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